Developing a Controlled Drugs*Standard Operating Procedure for Prescribers in Primary Care

Workbook

Developing a Controlled Drugs*Standard Operating Procedure for Prescribers in Primary Care

It is important that all staff involved in the prescribing process participate in the completion of this workbook, e.g. GPs, independent prescribers, practice manager and reception staff. This should take approximately 90 minutes.

The workbook should be completed using the CD SOP guidance document as a reference. All questions should be answered as fully and honestly as possible and the responses used as a basis to review current prescribing processes in the practice/organisation. The completed workbook shouldinform the basis of the practice’s SOP. One SOP should be developed for each practice/organisation and this should be signed-up to by all GPs and prescribers within the practice/organisation.

*This guidance applies to all schedules of controlled drugs

Section 1: Obtaining CD stock for GP bags

a) Do GPs order and collect their own CDs for their doctor’s bag?

Does each GP write and sign their own HS21S stock orders

(and not other staff members)? Y/N

Are stock orders written to comply with legislation? Y/N

Is there a mechanism to oversee the use of stock order forms for ordering CDs by locums, trainees or GPs without their own cipher number? Y/N

Does each GP use the same pharmacy each time they order their

CDs? Y/N

Do GPs keep the stock they order for their own use? Y/N

Is the stockever dividedfor use among partners? Y/N

b)What CDs are stocked in the doctor’s bag?

Where Schedule 2 and 3 CDs are stocked are these in Injectable

form only? Y/N

Are strengths of controlled drugs carried appropriate? Y/N

Is Naloxone stocked? Y/N

Are controlled drugs other than those required for immediate patient care stocked? Y/N

c)How are stock orders for CDs recorded?

Are retained copies of the order kept for 2 years? Y/N

Section 2: Receipt of CDs

Do GPs collect their own CD stock? Y/N

Does each GP have their own CD register? Y/N

For Schedule 2 CDs:

• is the CD register updated immediately upon receipt of CDs? Y/N
• Is a check of controlled drugs received made by the GP in the community pharmacy when the GP collects their CDs? Y/N

Are all CDs stored securely immediately upon receipt? Y/N

Section 3: Record Keeping for CDs – CD Registers

Does the CD register comply with current regulations? Y/N

Are running balances kept for each formulation of each drug? Y/N

Are records of all receipts and issues of Schedule 2 CDs made in

the CD register, at the time of receipt or issue or if that is not reasonably practicable, on the next day Y/N

.

Are CD registers readily availablefor review during inspections? Y/N

Are part ampoules ever used?Y/N

If yes, how are these recorded and is amount destroyed recorded? Y/N

Are registers kept for two years from the date of the last entry? Y/N

Section 4: Collecting CDs on behalf of patients

Does any GP ever collect dispensed CDs to deliver to patients? Y/N

Section 5: Storage of CDs

Is all medication including CDs, stored securely within the practice? Y/N

Does the storage of all Schedule 2 and certain Schedule 3 CDs

(e.g. buprenorphine, diethylpropion, flunitrazepam and temazepam) conform to the legislation? Y/N

Where are CDs stored?

Are doctors’ bags always locked when not in use? Y/N

Where are doctors’ bags stored when not in use?

Is a regular stock-check carried out of CDs held within the practice? Y/N

Does this include a check of expiry dates? Y/N

Are all controlled drugs in the doctors’ bags always stored in their

original or dispensed containers? Y/N

Does each GP take suitable precautions to protect the contents

of their bag from extremes of temperatures? Y/N

Does any GP hold any CDs prescribed for an individual patient

either in their bag or elsewhere in the practice? Y/N

When prescribing CDs do GPs advise patients about the appropriate storage of CDs in patients’ homes? Y/N

Section 6:Prescribing of CDs

Does the practice keep an up-to-date list of prescribers within the practice who can prescribe CDs? Y/N

Is this available for audit purposes? Y/N

Are computer systems used, wherever feasible, to generate a

CD prescription?Y/N

Are notes made of any CDs prescribed during domiciliary visits

as soon as possible after the visit?Y/N

Where it is necessary to handwrite a prescription for a CD, is this always done by the prescriber? Y/N

Are prescriptions for CDs written in line with legislation? Y/N

Are any CDs allowed on repeat prescription and what is the mechanism for review of this? Y/N

Whatquantity is normally supplied on a prescription for CDs?Y/N

Does the practice offer a substitute prescribing service?Y/N

If yes, do you have a SOP for the service? Y/N

Is this offeredunder the terms of a Local Enhanced Service?Y/N

Does the practice have a process for Read-coding and Notification

of Addicts including annual re-notification?Y/N

Are any schedule 2 and 3 CDs prescribed as part of a repeat Y/N

dispensing service?

Does the practice have a policy for private prescribing of CDs Y/N

Including use of PCD1 forms for Schedule 2 and 3 CDs?

Section 7:Administration of CDs

Is a valid authorisation from an authorised prescriber alwaysin

place for the administration of a CD to a patient?Y/N

Is the administration of a CD carried out by a different person than the one who hasprescribed, prepared, dispensed or transported the

CD?Y/N

Before administering a drug, is a check of the drug and patient identity always made? Y/N

Is a record of each administration made in the relevant section of the patient’s clinical notes that contains all the required details? Y/N

For schedule 2 CDs administered from stock is the appropriate entry made in the CD register? Y/N

Does the practice have processes in place to ensure safe medication practice for the preparation and administration of injections, including CDs? ` Y/N

Section 8:Checks of CD stock holding

For Schedule 2 CDs is the running balance of drug remaining calculated and recorded after each transaction, and balances

checked with the physical amount of stock at regular intervals?Y/N

Does each GP reconcile his/her own CD stock? Y/N

Are such checks initialled and dated to provide a verifiable Y/N audit trail.

Are balance checks done in the presence of, and countersigned by, another appropriately trained member of staff? Y/N

Do balance checks include checking the expiry date of stock? Y/N

Section 9:Dealing with discrepancies in Controlled Drugs’ balance

Does the practice have a procedure for dealing with

discrepancies?Y/N

What is the recommended course of action if a discrepancy

occurs?

Are appropriate records kept of the action taken when discrepancies arise? Y/N

Section 10:Destruction of CDs

How are unused portions e.g. ampoules, syringe driver managed?

How is out- of- date stock managed?

What records are made of out –of- date stock?

How ispatients’ own CD medication managed?

Section 11: Management of Incidents involving CDs

How are incidents involving CDs managed in the practice?

Does everyone in the practice know who should be informed,

should an incident arise?Y/N

Section 12: Self assessment declaration

Are all GPs aware of this form and the need for it to be completed and returned to the Board? Y/N

Are there procedures in place for the initial and continuing

training of staff involved in the management of CDs?Y/N

Section 13: Monitoring and auditing of prescribing data

Are all relevant staff aware of the COMPASS CD page and is

there a process in place to respond to any queries from Board

staff about this?Y/N

Are audits on CD prescribing available in the practice and used

as appropriate? Y/N

Are processes in place to review patients receiving CDs?Y/N

Section 14: Management of CDs by GPs whose prescribing rights change

Are all prescribers aware of the action necessary when their CD prescribing rights change? Y/N

Section 15: Additional section to be completed by Dispensing Doctor practices

Are all dispensing doctors and staff involved in the dispensing process aware of the current legislation for managing all aspects of the CD dispensing process? Y/N

Are procedures in place to ensure ordering, receipt, recording, storage, dispensing and supply of controlled drugs is in line with legal requirements? Y/N

Are all prescriptions for controlled drugs checked by a doctor? Y/N

Section 16: Additional section to be completed by Out-of-Hours’ centres

How do GPs working in the OOH centre obtain their CDs for use during OOHs?

Does the OOH centre have processes in place for use of stockorder forms by GPs for ordering CDs? Y/N

Are details of the local palliative care network available to all prescribers? Y/N

Are local procedures in place for managing requests from drug misusers for opiate substitutes during OOHs? Y/N

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